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Recombinant DNA and the Birth of Biotech

Recombinant Drugs

After figuring out how to grow recombinant bacteria on an industrial scale and how to harvest the insulin they produce, it was time to bring the recombinant insulin to the market. In 1982 Food and Drug Administration approved Humulin, Eli Lily’s recombinant insulin made from Genentech’s specially modified bacteria. It was the first drug produced through recombinant DNA technology and among the first genetically engineered products to be available to consumers.

Following the success of Humulin, recombinant DNA technology was quickly adopted to replace older methods of producing medical products from human growth hormone to vaccines. Although scientists have since developed new biotechnology techniques, recombinant DNA still plays an important role in the production of several major medical products. Among the objects below are several of the early formulations of Humulin as well as some of the other early recombinant pharmaceuticals produced in the 1980s and 1990s.

Activase is a recombinant pharmaceutical that is administered intravenously. Approved by the FDA on November 13, 1987, it contains tissue plasminogen activator (tPA), an enzyme that helps dissolve blood clots. Although Activase was originally developed to treat heart attack (acute myocardial infarction), it is now also used to treat stroke (acute ischemic stroke) and blood clots in the lungs (pulmonary embolism).

Recombinant pharmaceuticals are created by inserting genes from one species into a host species, often yeast or bacteria, where they do not naturally occur. The genes code for a desired product, and therefore the genetically modified host organisms can be grown and used as a kind of living factory to produce the product. In this case, genes coding for tPA are inserted into cultured Chinese hamster ovary cells. The ovary cells produce tPA, which is harvested and used as the active ingredient in Activase.

Object consists of a white cardboard box with red and blue printing. Box contains one round clear glass bottle with blue plastic cap and white label. Bottle is about 1/3 full of white powder. Box also contains bubblewrap and one insert. Package indicates that the box once also contained 50mL of sterile water for preparing injection solutions.